MAUDE Adverse Event Report: MOBIUS IMAGING, LLC AIRO CT SCANNER; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number	MOBICT-32
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Codes	Fall (1848); Laceration(s) (1946)
Date of Event	08/03/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a case, the airo tipped and the patient shifted off the table.The physician's assistant caught the patient's head and due to the impact from the catch, the patient experienced mild lacerations.The procedure was not completed successfully and the patient will be rescheduled for surgery.
Event or Problem Description
It was reported that during a case, the airo tipped and the patient shifted off the table.The physician's assistant caught the patient's head and due to the impact from the catch, the patient experienced mild lacerations.The procedure was not completed successfully and the patient will be rescheduled for surgery.
Additional Manufacturer Narrative
Device remained in field.

• Brand Name: AIRO CT SCANNER
• Common Device Name: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): MOBIUS IMAGING, LLC; 2 shaker road; suite f100; shirley MA 01464
• Manufacturer (Section G): MOBIUS IMAGING, LLC; 2 shaker road; suite f100; shirley MA 01464
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 15347426
• Report Number: 3010151377-2022-00001
• Device Sequence Number: 11894538
• Product Code: JAK
• UDI-Device Identifier: 00869346000200
• UDI-Public: 00869346000200
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K131431
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MOBICT-32
• Device Catalogue Number: MOBICT-32
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/03/2022
• Supplement Date Received by Manufacturer: 10/31/2022
• Initial Report FDA Received Date: 09/02/2022
• Supplement Report FDA Received Date: 11/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown